Evaluate the Effect of ALLN-177 in Reducing Urinary Oxalate in Patients With Hyperoxaluria and Kidney Stones

Allena Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Dietary Hyperoxaluria; Hyperoxaluria; Secondary Hyperoxaluria; Kidney Stones; Nephrolithiasis

Treatments: Drug: ALLN-177 low dose; Drug: ALLN-177 high dose; Drug: Placebo; Drug: ALLN-177 mid dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT02503345

0000649

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, tolerability, and efficacy of different doses of ALLN 177 for reducing urinary oxalate excretion in patients with secondary hyperoxaluria and recurrent kidney stones.

Full description

This is a multicenter, randomized, double-blind, placebo controlled study to evaluate the efficacy of ALLN 177 compared with placebo in reducing the urinary excretion of oxalate in subjects with secondary hyperoxaluria and kidney stones. ALLN-177 is an orally administered form of oxalate decarboxylase. The goal of therapy with ALLN-177 is to reduce urinary oxalate excretion by decreasing the absorption of oxalate from the gastrointestinal tract.

Eligible subjects will be randomized to 7 days of treatment with a dose ALLN-177 or placebo and following a washout period, crossed over to an alternate treatment. Urinary oxalate excretion will be assessed by 24-hr urine collections throughout the study.

The study allows for up to 60 subjects.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• History of enteric or idiopathic hyperoxaluria and at least one kidney stone within the past 2 years
• Hyperoxaluria at screening
• May be taking drugs for the prevention of stone disease

Exclusion criteria

• Hyperuricosuria
• Glomerular filtration rate < 55 mL/min/1.73m2
• Hypercalcemia or hypothyroidism
• Obstructive uropathy, chronic urosepsis, renal failure, renal tubular acidosis, primary hyperparathyroidism, primary hyperoxaluria, pure uric acid and cystine stones, and/or medullary sponge kidney
• Treatment with cholestyramine
• Average daily dietary intake of oxalate <75 mg per day

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

---

32 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo capsules (1, 2 or 5) PO TID

Treatment:

Drug: Placebo

ALLN-177 low dose

Experimental group

Description:

ALLN-177 1,500 units/meal PO TID

Treatment:

Drug: ALLN-177 low dose

ALLN-177 mid dose

Experimental group

Description:

ALLN-177 3,000 units/meal PO TID

Treatment:

Drug: ALLN-177 mid dose

ALLN-177 high dose

Experimental group

Description:

ALLN-177 7,500 units/meal PO TID

Treatment:

Drug: ALLN-177 high dose